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Feasibility of Aerodigestive Stimulation Therapy Trial
Sponsor: Sudarshan Jadcherla
Summary
The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are: * To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding. * To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding. Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.
Official title: Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
Key Details
Gender
All
Age Range
1 Day - 8 Months
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-02-05
Completion Date
2027-11-01
Last Updated
2024-10-04
Healthy Volunteers
No
Conditions
Interventions
Esophageal stimulation with high resolution esophageal manometry and nutritive oral feeding therapy
Subjects will be given weekly pharyngo-esophageal stimulation guided by high resolution impedance manometry for 4 weeks. During this time of study intervention, every feed will start with nutritive oral stimulation with at least 5 mL of the infant's prescribed diet.
Locations (1)
Nationwide Children's Hospital
Columbus, Ohio, United States